A Signal Of Myocarditis / Pericarditis Associated With Pfizer-BioNTech’s Covid-19 Vaccine, Comirnaty (Bnt162b2)

The South African Health Products Regulatory Authority (SAHPRA) would like to inform you of a signal of myocarditis/pericarditis associated with Pfizer-BioNTech’s Covid-19 vaccine, Comirnaty® (BNT162b2). The Pfizer/BioNTech Comirnaty® Vaccine was approved by SAHPRA in March 2021. The authorisation was done in terms of Section 21 of the Medicines and Related Substance Act, (Act 101 of 1965) as amended, a mechanism in the Medicines Act that enables emergency use access subject to certain conditions.